EPA underestimates, oversimplifies, miscommunicates, and mismanages cancer risks by ignoring human susceptibility

If exposed to an identical concentration of a carcinogen, every human being would face a different level of risk, determined by his or her genetic, environmental, medical, and other uniquely individual characteristics. Various lines of evidence indicate that this susceptibility variable is distributed rather broadly in the human population, with perhaps a factor of 25- to 50-fold between the center of this distribution and either of its tails, but cancer risk assessment at the EPA and elsewhere has always treated every (adult) human as identically susceptible. The National Academy of Sciences "Silver Book" concluded that EPA and the other agencies should fundamentally correct their mis-computation of carcinogenic risk in two ways: (1) adjust individual risk estimates upward to provide information about the upper tail; and (2) adjust population risk estimates upward (by about sevenfold) to correct an underestimation due to a mathematical property of the interindividual distribution of human susceptibility, in which the susceptibility averaged over the entire (right-skewed) population exceeds the median value for the typical human. In this issue of Risk Analysis, Kenneth Bogen disputes the second adjustment and endorses the first, though he also relegates the problem of underestimated individual risks to the realm of "equity concerns" that he says should have little if any bearing on risk management policy. In this article, I show why the basis for the population risk adjustment that the NAS recommended is correct-that current population cancer risk estimates, whether they are derived from animal bioassays or from human epidemiologic studies, likely provide estimates of the median with respect to human variation, which in turn must be an underestimate of the mean. If cancer risk estimates have larger "conservative" biases embedded in them, a premise I have disputed in many previous writings, such a defect would not excuse ignoring this additional bias in the direction of underestimation. I also demonstrate that sensible, legally appropriate, and ethical risk policy must not only inform the public when the tail of the individual risk distribution extends into the "high-risk" range, but must alter benefit-cost balancing to account for the need to try to reduce these tail risks preferentially.